3-months Success Rate of Direct Pulp Capping With Biodentine®

University Hospital, Brest40 enrolled

Overview

Biodentine® is a most recent material for direct pulp capping. The aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®.

Context : When a pulpal exposure happens on a vital tooth (without irreversible inflammation), direct pulp capping can be realized by using different biomaterials : CaOH2, MTA or Biodentine®. Biodentine® is the most recent material and its success rate for direct pulp capping is poorly documented. Objective : The main aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®. The other aims are to determine the factors which have an influence over the success or the failure of direct pulp capping. Method : The patient's non-opposition is obtained after a loyal explanation of the study in order to collect clinical data, if a pulpal exposure (\<2mm) happens on a vital tooth during decy excavation. The operator registers the following data: age of the patient, type of the concerned tooth, volume of coronal pulp, surface of the pulp exposure, location, area and duration of pulp bleeding. An evaluation is realized 3 months later with the same clinical evaluation and a radiographic evaluation. If the pulp vitality is normal, the final coronal filling is then realized. A statistical analysis will be performed to determine the success rate (binomial distribution with p=0.05). The predictive factors of success or failure will be analyzed with a logistic regression (with p=0.05).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dental Pulp Capping

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients with a small pulp exposure (\<2mm) created during decy removal on a vital tooth * absence of spontaneous pain, of fistula, of swelling, of mobility, of periodontal enlargement, of resorption, of periapical pathosis, of furcation defect, on this tooth * normal periodontal probing around this tooth * cold vitality test : positive but non increased on this tooth Exclusion Criteria: * patient with at risk of endocarditis, * patient with allergic reactions to a product used in the protocol, * patient with a lack of oral hygiene, * tooth with spontaneous pain, fistula, swelling, increased mobility, periodontal enlargement, resorption, periapical pathosis, furcation defect, pulpal necrosis, pulpal irreversible inflammation, excessive dental destruction, very abundant pulp bleeding, impossible set-up of the rubber dam * tooth with a pulp exposure \>2mm

Locations (1)

Chevalier

Brest, France

Outcomes

Primary Outcomes

Treatment success

Treatment success will be asses only if clinical AND radiographic examination are successful

Time frame: 3 months after the dental direct pulp capping

Data from ClinicalTrials.gov

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